Citrate Anticoagulant Improves the Sensitivity of Borreliella (Borrelia) burgdorferi Plasma Culture.
Adriana R Marques, Xiuli Yang, Alexis A Smith...
https://pubmed.ncbi.nlm.nih.gov/28878005Actively Recruiting
Age: 13Years - 99Years
All Genders
Healthy Volunteers
ID00001539
A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-06-05
700
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating whether patients infected with the Lyme disease bacteria, Borrelia burgdorferi, who have been treated with antibiotics still harbor live bacteria that cause ongoing symptoms. The study aims to help develop strict diagnostic criteria for Lyme disease and inform future treatment trials. It includes people with chronic Lyme disease, Lyme arthritis, seropositive controls without symptoms, recovered patients, multiple sclerosis patients, and healthy volunteers. Participants will undergo physical exams and various tests including blood tests for immune markers, leukapheresis to collect white blood cells or a smaller blood draw, lumbar puncture to collect spinal fluid, brain MRI scans, neuropsychological tests, hearing tests, and urine collection. Those testing positive for the bacteria will be followed regularly and offered antibiotic treatment with ceftriaxone. Follow-up visits will include repeat testing and imaging to monitor treatment response. Some participants may be reevaluated every 6 to 12 months. Throughout the study, participants will be monitored with blood and urine tests, lumbar punctures, hearing exams, MRI scans, and neuropsychological assessments. The research team will collect data to understand the biological markers and immune responses in post-treatment Lyme disease syndrome. The study is ongoing, with regular follow-ups to assess clinical outcomes, treatment effects, and to build a detailed patient database for future research.
CONDITIONS
Brief Title
A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
Who Can Participate
Age: 13Years - 99Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age 13 years or older (13+ for post-treatment Lyme disease syndrome group; 18+ for all other groups)
- Diagnosed with confirmed or probable Lyme disease according to CDC criteria (for post-treatment Lyme disease syndrome)
- Received recommended antibiotic therapy for Lyme disease (for post-treatment Lyme disease syndrome)
- Persistent or relapsing symptoms for at least six months after antibiotic therapy (for post-treatment Lyme disease syndrome)
- Intermittent arthritis involving one or a few joints with positive serum antibodies to B. burgdorferi (for Lyme arthritis controls)
- Previously treated and recovered from Lyme disease, currently asymptomatic (for recovered controls)
- Positive serum IgG antibody to B. burgdorferi but asymptomatic and untreated (for seropositive controls)
- Received at least two doses of the OspA vaccine (for OspA vaccinated controls)
- Diagnosed with multiple sclerosis with no evidence of prior Lyme disease exposure (for multiple sclerosis controls)
- Healthy with no history or serological evidence of Lyme disease (for healthy volunteers)
You will not qualify if you...
- Age under 13 for post-treatment Lyme disease syndrome group; under 18 for all other groups
- Weight less than 70 pounds (35 kg)
- Pregnancy or lactation
- Women of childbearing potential unwilling to use effective contraception during study phases
- Positive tests for syphilis, hepatitis B, hepatitis C, or HIV
- Use of immunosuppressive drugs such as systemic steroids or cytotoxic agents (for PTLDS and Lyme arthritis groups)
- History of autoimmune diseases like rheumatoid arthritis or lupus (for PTLDS and Lyme arthritis groups)
- Serious chronic medical or psychiatric illnesses unrelated to Lyme disease
- Significant head trauma, substance abuse, or neurologic illness within past 5 years
- Use of systemic antibiotics within the previous month
- Use of immunomodulators such as interferons
- Inability to give informed consent or comply with study requirements
- Pre-existing serious illnesses in control groups as specified
- Previous treatments like total lymphoid irradiation or certain immunoactive medications in multiple sclerosis controls
- Enrolled participants who become pregnant during the study will be withdrawn
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Duration of the study
Participants undergo clinical, microbiological, and immunological assessments to characterize post-treatment Lyme disease syndrome and control conditions.
1 or more visits depending on cohort assignment
Long-term Monitoring
Duration - Duration of the study
Participants are followed over time to observe clinical course, outcomes, and biological markers related to post-treatment Lyme disease syndrome.
Periodic visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
A
Ashley M Thomas
A
Adriana R Marques, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
8
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